FDA — authorised 12 June 1981
- Application: NDA018533
- Marketing authorisation holder: JANSSEN PHARMS
- Local brand name: NIZORAL
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Nizoral in United States
FDA authorised Nizoral on 12 June 1981
Marketing authorisations
FDA — authorised 31 December 1985
- Application: NDA019084
- Marketing authorisation holder: JANSSEN PHARMA
- Local brand name: NIZORAL
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 31 August 1990
- Application: NDA019927
- Marketing authorisation holder: JANSSEN PHARMS
- Local brand name: NIZORAL
- Indication: SHAMPOO — TOPICAL
- Status: approved
FDA — authorised 10 October 1997
- Application: NDA020310
- Marketing authorisation holder: KRAMER
- Local brand name: NIZORAL ANTI-DANDRUFF
- Indication: SHAMPOO — TOPICAL
- Status: approved
FDA — authorised 15 June 1999
- Application: ANDA075273
- Marketing authorisation holder: TEVA
- Local brand name: KETOCONAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 June 1999
- Application: ANDA074971
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: KETOCONAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 June 1999
- Application: ANDA075362
- Marketing authorisation holder: HERITAGE PHARMA
- Local brand name: KETOCONAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 June 1999
- Application: ANDA075319
- Marketing authorisation holder: TARO
- Local brand name: KETOCONAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 June 1999
- Application: ANDA075314
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: KETOCONAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 July 1999
- Application: ANDA075341
- Marketing authorisation holder: AAIPHARMA LLC
- Local brand name: KETOCONAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 December 1999
- Application: ANDA075597
- Marketing authorisation holder: AUROBINDO PHARMA USA
- Local brand name: KETOCONAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 April 2000
- Application: ANDA075581
- Marketing authorisation holder: TEVA
- Local brand name: KETOCONAZOLE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 10 January 2002
- Application: ANDA075912
- Marketing authorisation holder: SENORES PHARMS
- Local brand name: KETOCONAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 December 2002
- Application: ANDA075638
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: KETOZOLE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 28 April 2004
- Application: ANDA076294
- Marketing authorisation holder: FOUGERA PHARMS
- Local brand name: KETOCONAZOLE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 11 April 2005
- Application: ANDA076942
- Marketing authorisation holder: COSETTE
- Local brand name: KETOCONAZOLE
- Indication: SHAMPOO — TOPICAL
- Status: approved
FDA — authorised 28 July 2006
- Application: NDA021946
- Marketing authorisation holder: INA PHARMS
- Local brand name: XOLEGEL
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 25 August 2011
- Application: ANDA091550
- Marketing authorisation holder: PADAGIS ISRAEL
- Local brand name: KETOCONAZOLE
- Indication: AEROSOL, FOAM — TOPICAL
- Status: approved
FDA — authorised 18 June 2018
- Application: ANDA210457
- Marketing authorisation holder: STRIDES PHARMA
- Local brand name: KETOCONAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 May 2021
- Application: ANDA212443
- Marketing authorisation holder: ENCUBE
- Local brand name: KETOCONAZOLE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 21 May 2021
- Application: ANDA213601
- Marketing authorisation holder: XIROMED
- Local brand name: KETOCONAZOLE
- Indication: AEROSOL, FOAM — TOPICAL
- Status: approved
FDA — authorised 17 November 2021
- Application: ANDA215185
- Marketing authorisation holder: PADAGIS US
- Local brand name: KETOCONAZOLE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 16 September 2024
- Application: ANDA218498
- Marketing authorisation holder: NOVITIUM PHARMA
- Local brand name: KETOCONAZOLE
- Indication: SHAMPOO — TOPICAL
- Status: approved
FDA — authorised 7 March 2025
- Application: ANDA218559
- Marketing authorisation holder: ZYDUS LIFESCIENCES
- Local brand name: KETOCONAZOLE
- Indication: SHAMPOO — TOPICAL
- Status: approved
FDA
- Application: ANDA070767
- Marketing authorisation holder: JANSSEN PHARMA
- Local brand name: NIZORAL
- Indication: SUSPENSION — ORAL
- Status: approved
FDA
- Status: approved
Nizoral in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Infectious Disease approved in United States
Frequently asked questions
Is Nizoral approved in United States?
Yes. FDA authorised it on 12 June 1981; FDA authorised it on 31 December 1985; FDA authorised it on 31 August 1990.
Who is the marketing authorisation holder for Nizoral in United States?
JANSSEN PHARMS holds the US marketing authorisation.